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Abstract
Introduction/Background An initial publication of the GEICO-88R study (NCT04546373) evaluated niraparib as maintenance therapy in patients (pts) with platinum-sensitive recurrent high-grade ovarian cancer (OC), within an expanded access programme developed in Spain. A subgroup assessment of pts ≥75 years of age has now been performed.
Methodology GEICO conducted a retrospective study in which 40 Spanish hospitals registered OC patients, 75 years or older, who received maintenance niraparib at fixed (FSD, 300 mg/day) or individualised starting dose (ISD) according to weight and platelet count. Toxicity, dose management, patient characteristics, and effectiveness were assessed using source data from medical records.
Results Forty-two pts were enrolled with the characteristics shown in table 1. Of the 37 patients who underwent surgery at diagnosis, 48.6% and 51.4% had a primary and interval debulking surgery respectively, achieving R0 in 67.6%. At recurrence 4 pts (9.5%) underwent surgery (R0 in 3). Niraparib was started at FSD in 11 pts and at ISD in 31 (all at 200 mg/day). Median treatment duration was 4.8 months (median dose 200 mg). 52.3% of pts required ≥1 interruptions, and the same percentage ≥1 reductions. Three pts were still on treatment at the time of analysis and 39 had discontinued (87.2% progression, 5.1% toxicity, 5.1% physician/pts decision). The most common all-grade treatment-related adverse events were: thrombocytopenia (40.5%), asthenia (38.1%), anaemia (23.8%), nausea (21.4%), and hypertension (14.3%). For 39 evaluable pts, the median progression free survival (mPFS), PFS2 and overall survival were 4.4 (95% CI 3.1–7.2), 13 (10.3–16.6) and 23 (95% CI 18.1–26.2) months, respectively.
Patient characteristics
Conclusion In the GEICO-88R study, OC pts with 75 years or older present the expected age-related comorbidities and are treated similarly to the general OC population. Maintenance niraparib is well tolerated in this age group. This subanalysis provides valuable information on a subpopulation of OC with few published data.